Efficiency Tips: Spend less time on Monitoring Visit Reports

As a monitor, you may visit several different study sites in a single week and possibly for different protocols. I often find when I get home from a trip like that it is hard to write my report and keep the details of the different sites straight. One thing I have done to successfully overcome that is to draft my report before I even do the visit. On most studies, your Lead will provide you with a template report that you will need to complete following each visit type. You might also use an electronic system to create your reports but luckily, mine are usually just MS Word templates. Every report is guaranteed to have a header section that includes the MD name, facility name and address, visit type, visit date, date of last visit, and list of attendees. You probably know all of this information before you step foot on the site so just fill it in before you go.

Things I am unsure about I highlight in yellow so I remember to return to them later. Unless this is your first visit to the site, chances are there is a previous report completed by either you or another CRA that has items that probably need to be carried over to your current report. You will want to refer to your company's SOPs and your project-specific monitoring plan to know which items get carried forward. On some of my recent reports, this has included Enrollment data (I can usually get the current number of Screened, Screen Failed, Enrolled, Early Term, and Completed subjects from the IVRS system before I even show up for the visit), summaries of Protocol Deviations to date (they stay on the report until the IRB acknowledges receipt of the deviation), SAEs that are not resolved, Regulatory Documents that need to be collected, and pending Action Items or those that have been resolved since the last report date.

Drafting your report before the visit has the added benefit of helping you write your confirmation letter and get a grasp on what activities need to take place during the visit. You will be organized before you get there and more likely to monitor efficiently if you know exactly what is outstanding.

While you are at the site, avoid keeping notes on notebook paper; just write pending items directly into the Action Items or other applicable section of your report. If the items you notes are resolved by the time you leave you may decide to dump them from your report (depending on how much detail your company/sponsor is looking for) and if not, mark them pending and submit them as part of your draft.

When I am at the airport waiting for my flight to board, I can usually knock off a draft report in about 20-30 minutes. Then when I have internet access, I just submit it and forget it (or at least until I get a revisions request)! What efficiency tips work for you?

Not getting any work done in the airport terminal?
Your company may reimburse you for airport lounge
access or you can typically get a discount pass through
loyalty to an airline or credit card offers.  In the lounge
you can be productive, enjoy snacks and beverages,
access the internet and a business center plus plug
in all of your devices.  

Home from the Investigator's Meeting

I've been assigned another study and attended a kickoff and Investigator Meeting on the East Coast last week. As I mentioned in my last post, an Investigator's Meeting is basically a chance to get all the doctors and staff together at one venue with the sponsor (usually a fancy hotel or somewhere fun) so that all the details of the study protocol can be reviewed and everyone's questions get answered. Also, because a lot of money is spent at these meetings to woo, wine, and dine the Principal Investigators (PIs), the meeting has the bonus effect of getting everyone psyched up and excited/competitive about enrolling in the study.

For my new study (it is a high cholesterol drug therapy study) I will have 11 sites each of which needs to be visited at least every 4 weeks depending on enrollment. There are 60 PIs total and 4 other CRAs but I am the only one on the West Coast. I am lucky that 7 of my sites are located near one another in LA so I can combine my visits into longer trips and not have to fly so often. I also have 2 sites in Phoenix, a site in Seattle, and a site 1.5 hrs drive East of my house. In any case, this is a heavy site load but luckily it is a straightforward study and the PIs seem to be both experienced and motivated.

An electronic patient diary looks just
like a little PDA and the patient gets
an alarm to remind them it is time
to take their medicine or fill out a
little outcomes summary. This data
gets sent in via the telephone or
loaded into a computer and is used
in the study analysis.

The trial leverages some cool technology such as an electronic data capture system (so CRFs go into the computer in an EDC system rather than on triplicate forms) and the patients all get electronic diaries (little palm pilot devices) so they can capture adverse events and be reminded when it is time to take their medicine, plus the medicine (Investigational Product - IP) comes in blister packs one week at a time, so drug accountability should be a cinch thanks to this clever packaging. This is a proof of concept study so there are 6 different study arms (some patients get placebo, some get the real drug, some get a mix of both...) and only 275 subjects will be enrolled. The subjects take their meds for around 7 weeks. Recruitment is anticipated to end in mid-April so it is a really short enrollment period. The Inclusion exclusion criteria are very tight so a high number of screen failures are expected (up to 800). Luckily, screen failures will not get their own casebooks but just be captured in the Integrated Voice Response System (IVRS) web portal.

In my next post I will tell you more about how to prepare for a CRA interview and what types of questions you can expect to be asked. Then I will post about Routine Monitoring Visits, as promised. Let me know if there are other topics that are of interest to you by emailing me or leaving me a comment here and I will be sure to address them in future posts.